Biogen: It's Unlikely Patient Death Was Caused By Tecfidera

For a brief moment, there was significant investor anxiety that the 'holy mother' of all drug launches might burst like a balloon. A report that the new Tecfidera multiple sclerosis pill was possibly linked to a patient death sent shares downward amid speculation about whether the
Biogen Idec drug may have a side effect problem that could thwart blockbuster sales estimates.

But by the time the markets closed, the drugmaker had worked feverishly to dispel such concerns. The patient, a 59-year-old woman, was treated with Tecfidera for nearly six weeks, but discontinued use due to gastrointesinal symptoms, such as nausea, vomiting and diarrhea. These subsequently abated, but she died two and a half weeks later from bilateral pneumonia, a Biogen spokeswoman says.

This occurs more frequently in MS patients. Moreover, the patient also had a history of irritable bowel disease and recurring infections, including bronchitis. "This is an important detail," says the spokeswoman. The death "is not GI-related... Based on the circumstances and cause of death , a link to Tecfidera is unlikely.

Just the same, Biogen is going to have continue with its analysis. "It's all relatively new," the spokeswoman acknowledges. "This is based on information we’ve been able to confirm. It will probably be awhile before we have more definitive information. But based on what we know at this point, this is the first case like this."

For now, Wall Street analysts are sanguine. "I see this as a non-issue," ISI Group analyst Mark Schoenebaum wrote in a note to clients. "Please chillax." Indeed, Biogen shares regaining lost ground in after-hours trading. The drug has frequently generated double-digit, week-over-week increases in total prescriptions since its April launch. Leerink Swann analyst Mario Kozul looks for annual revenue to hit $3 billion by 2017.

I've followed the pharmaceutical industry since 1995. This ride began at The Star-Ledger of New Jersey and continues with Pharmalot, which I have run since 2007. Along the way, I was also an editor at The Pink Sheet. Before covering pharma, I worked for several years at New ...